Efficacy and Safety of Four Escalating Dose Regimens of TPI ASM8 in Patients With Allergic Asthma
NCT00822861 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2013-11-15
Summary
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
Conditions
Interventions
- DRUG
-
TPI ASM8
4 mg/mL, 1 mg BID for 4 days
- DRUG
-
TPI ASM8
4 mg/mL, 2 mg BID for 4 days
- DRUG
-
TPI ASM8
4 mg/mL, 4 mg BID for 4 days
- DRUG
-
TPI ASM8
4 mg/mL, 8 mg OD for 4 days
Sponsors & Collaborators
-
Syntara
lead INDUSTRY
Principal Investigators
-
Rene Pageau, B.Pharm M.Sc · Topigen Pharmaceuticals Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-04-30
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- Canada
Study Locations
More Related Trials
-
Multiple Rising Dose Study of BI 144807 Powder in Bottle in Mild Asthmatic Patients
NCT01651598 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma
NCT01793298 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Oral Administration of AIM-102 in Patients With Mild to Moderate Allergic Asthma
NCT01501942 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Clinical Activity of ASM-024 in Subjects With Mild Allergic Asthma
NCT01092403 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Effect of AZD8154 Administered Via Nebulizer Once Daily in Subjects With Mild Allergic Asthma Challenged With an Inhaled Allergen
NCT04187508 ·Status: WITHDRAWN ·Phase: PHASE2
-
A Study to Evaluate the Pharmacodynamic, Efficacy and Safety of SHR-1703 in Asthma Patients With Eosinophil Phenotype
NCT05522439 ·Status: COMPLETED ·Phase: PHASE2
-
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
NCT02105012 ·Status: COMPLETED ·Phase: PHASE2
-
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
NCT04150341 ·Status: COMPLETED ·Phase: PHASE2
-
Inhaled TPI-1020 Versus Inhaled Budesonide in Smokers With Mild Reversible Asthma
NCT00327808 ·Status: COMPLETED ·Phase: PHASE2
-
A 12-Week Study in Asthmatic Children Ages 6 to <12 Years, Investigating the Efficacy and Safety of Symbicort pMDI 80/2.25 μg and Symbicort pMDI 80/4.5 μg, Compared With Budesonide pMDI 80 μg
NCT02091986 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma
NCT01190826 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects
NCT04772365 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Salmeterol on Eosinophil (EOS) Function
NCT00214019 ·Status: COMPLETED ·Phase: NA
-
The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics
NCT00625989 ·Status: COMPLETED ·Phase: EARLY_PHASE1
-
A Single Ascending Dose Study in Healthy Participants and Multiple Ascending Dose Study of CNTO 7160 in Participants With Asthma and Participants With Atopic Dermatitis
NCT02345928 ·Status: COMPLETED ·Phase: PHASE1
-
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
NCT00244608 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
NCT05763121 ·Status: TERMINATED ·Phase: PHASE3
-
Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma
NCT02334553 ·Status: COMPLETED ·Phase: PHASE2
-
The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen
NCT01225549 ·Status: COMPLETED ·Phase: PHASE2
-
A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma
NCT02479412 ·Status: COMPLETED ·Phase: PHASE2
-
Study In Asthma Control
NCT00273026 ·Status: TERMINATED ·Phase: PHASE4
-
A Clinical Study to Evaluate Symbicort Turbuhaler Used 'as Needed' in Adults and Adolescents With Asthma
NCT02224157 ·Status: COMPLETED ·Phase: PHASE3
-
A Single Ascending Dose Study of R1671 in Patients With Mild Intermittent Asymptomatic Asthma.
NCT00517816 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluation of AZD8154 Concentrations in Blood
NCT04480879 ·Status: TERMINATED ·Phase: PHASE1
-
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
NCT02980133 ·Status: COMPLETED ·Phase: PHASE3